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Alcon refiles NDA for Patanase

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

After pulling its Patanase (olopatadine) nasal spray NDA in November 2005, Alcon resubmits the application with an amendment to modify its formulation. The amendment includes six-month data from an agreed-upon study requested by FDA to remove or reduce one of the inactive ingredients (1Pharmaceutical Approvals Monthly November 2005, In Brief). The pending NDA seeks approval of the ophthalmic solution, which has the same active ingredient as the firm's Patanol ophthalmic solution, for treatment of allergic rhinitis...

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